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This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, PK, and immunogenicity of APG777 in adult participants with mild-to-moderate asthma.
The duration of the study will be approximately 52 weeks (364 days) for each participant and will consist of a Screening Period, Treatment Period, and Follow-up Period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| APG777 | Experimental | Participants will receive protocol specified dose of APG7777 |
|
| Placebo | Placebo Comparator | Participants will receive matching placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| APG777 | Drug | APG777 subcutaneous injection |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment Emergent Adverse Events (TEAEs) | Up to 52 weeks | |
| Number of Participants with Abnormal Laboratory Findings | Up to 52 weeks | |
| Number of Participants with Abnormal Vital Signs | Up to 52 weeks | |
| Number of Participants with Abnormal Electrocardiograms (ECGs) | Up to 52 weeks | |
| Number of Participants with Abnormal Physical Examination Findings | Up to 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum concentration (Cmax) of APG777 | Up to 48 weeks | |
| Time to reach Cmax (tmax) | Up to 48 weeks | |
| Terminal elimination rate constant (λz) |
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Inclusion Criteria:
Exclusion Criteria:
Note: Other protocol defined criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site | La Jolla | California | 92037 | United States | ||
| Investigational Site |
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| Drug |
Matching placebo subcutaneous injection |
|
| Up to 48 weeks |
| Terminal Elimination half-life (t1/2) | Up to 48 weeks |
| Area Under the Serum Concentration-time curve (AUC) from Time 0 to the Last Quantifiable Time Point (AUC0-last) | Up to 48 weeks |
| AUC From Time 0 Extrapolated to Infinity (AUC0-inf) | Up to 48 weeks |
| Apparent Clearance of APG777 (CL/F) | Up to 48 weeks |
| Apparent Volume of Distribution (Vz/F) | Up to 48 weeks |
| Number of Participants with Anti-Drug-Antibodies (ADAs) | Up to 48 weeks |
| Cmax in Participants With and without ADAs | Up to 48 weeks |
| AUClast Participants With and without ADAs | Up to 48 weeks |
| AUCInf Participants With and without ADAs | Up to 48 weeks |
| Long Beach |
| California |
| 90808 |
| United States |
| Investigational Site | San Jose | California | 95117 | United States |
| Investigational Site | Torrance | California | 90505 | United States |
| Investigational Site | Normal | Illinois | 61761 | United States |
| Investigational Site | Kansas City | Missouri | 66160 | United States |
| Investigational Site | Edmond | Oklahoma | 73034 | United States |
| Investigational Site | Philadelphia | Pennsylvania | 19140 | United States |
| Investigational Site | Pittsburgh | Pennsylvania | 15241 | United States |
| Investigational Site | Bradford | West Yorkshire | BD9 6RJ | United Kingdom |
| Investigational Site | Manchester | M23 9QZ | United Kingdom |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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